System and methods for preventing intravasation during intrauterine procedures

ABSTRACT

Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. Patient benefit is achieved through improved outcomes, reduced pain, especially peri-procedural pain, and reduced recovery times. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor&#39;s office or clinic. Distension is achieved mechanically, rather than with liquid distension media, thereby eliminating the risk of intravasation.

PRIORITY INFORMATION

This application claims priority under 35 U.S.C. §119 to U.S.Provisional Patent Application Ser. No. 60/852,842, filed Oct. 18, 2006,the disclosure of which is incorporated in its entirety herein byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to systems, methods, apparatus and devicesfor performing one or more gynecologic and urologic procedures. Moreparticularly, devices and combinations of devices provide simplified useand enhanced safety to support performance of various diagnostic andtherapeutic procedures in the doctor's office setting.

2. Description of the Related Art

Currently available gynecologic products are difficult to use and oftenhave limited use and functionality. Treatment of gynecologic disordersand ailments is most often performed in a hospital and bears a largecost due to the setting and the support personnel required. Treatmentoptions and modalities are also limited, such that the patient may notbe offered the best option for her particular condition.

There is therefore a need for improved gynecologic systems, methods anddevices that simplify use, offer improved functionality and enhancedsafety.

SUMMARY OF THE INVENTION

There is provided in accordance with one aspect of the presentinvention, a method of preventing intravasation during an intrauterineprocedure. The method comprises the steps of transcervically accessingthe uterus with an elongate tubular sheath. A mechanical distensiondevice is introduced through the sheath and into the uterus. Themechanical distension device is used to distend the uterus and expose asite. A therapeutic or diagnostic procedure may be performed at thesite.

The transcervically accessing step may comprise advancing the sheathover a guidewire. The transcervically accessing step may be accomplishedunder local anesthesia.

The mechanical distension step achieves an equivalent distension to thatachieved by introduction of a liquid distension media at a pressure ofat least about 40 mm Hg. In some embodiments, the mechanical distensionstep is utilized to achieve an equivalent distension to that achieved byintroduction of a liquid distension media at a pressure of at leastabout 70 mm Hg.

The method may additionally comprise the step of dilating the cervixprior to the transcervically accessing step. The performing a procedurestep may comprise treating a uterine fibroid.

In accordance with another aspect of the present invention, there isprovided a method of performing a procedure in the uterus. The methodcomprises the steps of transcervically accessing the uterus with anelongate flexible tubular sheath, having a proximal end, a distal endand at least one lumen extending therethrough. The sheath has an outsidediameter of no more than about 9 mm.

The uterus is distended to expose a site, and a visualization device isintroduced through the sheath to visualize the site. A procedure isperformed at the site. The procedure may be a diagnostic procedure or atherapeutic procedure.

In some embodiments, the outside diameter of the sheath is less thanabout 8 mm, generally less than about 7 mm, and preferably less thanabout 6 mm.

Further features and advantages of the present invention will becomeapparent from the detailed description of preferred embodiments whichfollows, when considered together with the attached drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various embodiments of thepresent invention, and, together with the description, serve to explainthe principles of the invention. In the drawings:

FIG. 1 illustrates a perspective view of an exemplary embodiment of anintroducer consistent with the present invention;

FIG. 1A illustrates a side sectional view of another exemplaryembodiment of an introducer consistent with the present invention,wherein the introducer includes a pre-dilating balloon and is shownbeing deployed in the cervix of a patient;

FIG. 1B illustrates a side sectional view of another exemplaryembodiment of an introducer consistent with the present invention,wherein the introducer includes a drug delivery element and a straingauge and is shown deployed in the cervix of a patient;

FIG. 2 illustrates a side sectional view of an exemplary embodiment of asystem of the present invention, wherein an introducer includes aradiopaque ring and is shown deployed in the cervix, and a tissueremoval device with a side-saddle camera has been advanced through theintroducer and into the uterus of a patient;

FIG. 2A illustrates a side sectional view of the distal end of a tissueremoval device consistent with the present invention, wherein the deviceincludes an oscillating cutter;

FIG. 2B illustrates a side sectional view of the distal end of anothertissue removal device consistent with the present invention, wherein thedevice includes a rotating cutter;

FIG. 2C illustrates a side sectional view of the distal end of a tissueremoval device and side-saddle camera, consistent with the presentinvention;

FIG. 3 illustrates a side sectional view of another exemplary embodimentof a system consistent with the present invention, wherein an introduceris shown deployed in the cervix of a patient, and a subsonic treatmentdevice has been advanced through the introducer and into the uterus;

FIG. 3A illustrates a side view of the distal end of the subsonictreatment device of FIG. 3;

FIG. 4 illustrates a side view of another exemplary embodiment of anintroducer consistent with the present invention, wherein the introducerincludes a removable needle assembly and an inflatable balloon near itsdistal end;

FIG. 5 illustrates a side sectional view of another exemplary embodimentof a system consistent with the present invention, wherein an introduceris shown deployed through the vaginal wall of a patient and a treatmentdevice has been advanced through the introducer to a location outsidethe uterus and proximate a fibroid in the uteral wall;

FIG. 5A illustrates a side sectional view of another exemplaryembodiment of a system consistent with the present invention, wherein anintroducer is shown deployed through the vaginal wall of a patient, atreatment device including a magnet in its distal portion has beenadvanced through the introducer to a location outside the uterus and astabilizing magnetic device has been advanced into the uterus proximatea fibroid;

FIG. 6 illustrates a side sectional view of an exemplary methodconsistent with the present invention, wherein a first treatment devicehas been advanced through the cervix and a fallopian tube and isaccessing the outside of a fallopian tube, and a second treatment devicehas been advanced through the cervix and a fallopian tube and isaccessing the outside of the uterus proximate a fibroid;

FIG. 7 illustrates a side sectional view of an exemplary drug deliverydevice consistent with the present invention, wherein the device isdeployed in the cervix of the patient and integral needles are deployedinto the cervical wall;

FIG. 7A illustrates a side sectional view of the drug delivery device ofFIG. 7, wherein the needles are in the retracted position;

FIG. 7B illustrates a side sectional view of the drug delivery device ofFIG. 7, wherein the needles are in an deployed position;

FIG. 7C illustrates a side sectional view of another exemplary drugdelivery device consistent with the present invention, wherein thedevice includes a vacuum source and suction ports for attracting tissuetoward a drug delivery element;

FIG. 8 illustrates a side sectional view of another exemplary drugdelivery device consistent with the present invention, wherein thedevice is deployed in the cervix of the patient and integral exit holesallow fluid to pass into the cervical wall;

FIG. 8A illustrates a side view of the distal end of the drug deliverydevice of FIG. 8, wherein the device is deployed over an occludingguidewire;

FIG. 8B illustrates a side view of the proximal end of the drug deliverydevice of FIG. 8A.

FIG. 9 illustrates a side sectional view of another exemplary drugdelivery device consistent with the present invention, wherein thedevice is deployed in the cervix of the patient, an integral balloon hasbeen inflated and integral exit holes in the balloon allow fluid to passinto the cervical wall;

FIG. 9A illustrates a side view of the distal end of the drug deliverydevice of FIG. 9, wherein the device is deployed over a guidewire andthe balloon is inflated;

FIG. 9B illustrates a side view of the proximal end of the drug deliverydevice of FIG. 9A.

FIG. 10 illustrates a side sectional view of an exemplary scaffoldingdevice consistent with the present invention, wherein the device hasbeen deployed in the uterus of a patient;

FIG. 10A illustrates a side sectional view of the scaffolding device ofFIG. 10, wherein a control shaft has been near fully extended and ascaffold is partially deployed;

FIG. 10B illustrates a perspective view of an exemplary scaffoldingdevice consistent with the present invention, wherein the scaffoldingassembly comprises two resiliently biased arms;

FIG. 10C illustrates a perspective view of an exemplary scaffoldingdevice consistent with the present invention, wherein the scaffoldingassembly includes three resiliently biased arms;

FIG. 10D illustrates a side sectional view of the scaffolding device ofFIG. 10B, wherein the scaffolding device has been inserted through anintroducer of the present invention and has its distal portion in theuterus of a patient;

FIG. 11 illustrates a side sectional view of an exemplary visualizationapparatus consistent with the present invention, wherein a cameradevice, a first light source and a second light source have beenadvanced into the uterus of a patient;

FIG. 12 illustrates a side sectional view of another exemplary systemconsistent with the present invention, wherein a uteral volume occupyingdevice and a treatment device have each been advanced into the uterus ofa patient;

FIG. 12A illustrates a side view of an exemplary wire shaping deviceconsistent with the present invention;

FIG. 13 illustrates a flow chart of an exemplary method of dilation,consistent with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

To facilitate an understanding of the invention, a number of terms aredefined immediately herebelow.

As used herein, the term “trans-vaginal-wall” refers to devices orprocedures which enter the vaginal opening, travel down the vaginalcanal, and exit through the vaginal wall proximal to the cervix.

As used herein, the term “trans-cervical” refers to devices orprocedures which enter the vaginal opening, travel down the vaginalcanal, pass through the cervical canal and enter the uterus.

As used herein, the term “trans-uteral” refers to devices or procedureswhich pass through the wall of the uterus.

As used herein, the term “drug” refers to all drugs and other agentsthat may be included in the systems, methods apparatus and devices ofthe present invention; either by including the drug into a coating or anintegral reservoir of a component; or by provided to the patient throughother means such as via a lumen and exit port which is in fluidcommunication with a supply of the drug such as an infusion pump orsyringe. Drugs shall include not only pharmaceutical compounds such asanesthetics, anti-thrombotics, thrombotics, anti-bacterial drugs andchemotherapeutics, but also other agents such as ionic solutions,hormones, genes, vitamins, clotting agents, naturally occurringsubstances such as extracts from plants, and any other compound or agentapplicable to the procedures contained herein.

As used herein, “patient” refers to any animal, such as a mammal andpreferably a human. Specific examples of “patients” include but are notlimited to: individuals requiring medical assistance and healthyindividuals.

Systems, methods, apparatus and devices consistent with the inventionprovide improved diagnostic and therapeutic gynecologic and urologicprocedures and outcomes. The simplified, safer use provided allows theseprocedures to be performed in locations such as a doctor's office orhealth clinic, eliminating the high costs associated with a hospitalsetting. Specific devices of the present invention reduce the painencountered by the patient during and after the associated diagnostic ortherapeutic procedure. The devices and apparatus provide to theclinician operator precision in both manipulation and device actions,and often allow reversibility of one or more steps of the procedurewithout undesirable consequence. Inadvertent tissue trauma is avoidedwith blunting of tips and other tissue-contacting surfaces. Simplifiedmechanisms, miniaturized geometries and improved methods reduceprocedure times and trauma, and also the associated infection risk andblood loss. Intravasation, the entry of foreign matter in a bloodvessel, is also reduced.

An introducer is provided which can be placed into the patient toprovide a stabile, working platform to support simplified introductionof one or more diagnostic, treatment or other devices. The introducerincludes an elongate shaft with one or two or more internal lumens. Theproximal end of the shaft may include one or more access ports, such asfluid access ports and device entry ports, as well as one or morecontrols such as buttons, knobs or levers used to manipulate theintroducer or activate a mechanical or electronic module of theintroducer. The introducer preferably accepts devices comprisingelongate shafts, sequentially or simultaneously. The introducer systemalso permits the administration and or removals of fluid from thepatient, such as fluid administered to the uterus, while also providingfluid stasis or maintaining stasis to a maximum pressure at which fluidcan be automatically evacuated. The introducer system also permits theadministration of one or more drugs, such as anesthetic drugs orclotting agents. The introducer system may be introduced through thecervix and into the uterus, through the vaginal wall to a locationoutside the uterus (trans-vaginal-wall), or through another entry pathto a specific anatomical location within the patient.

Systems are provided that enable and/or perform diagnostic, therapeuticor combined diagnostic and therapeutic gynecologic and urologicprocedures. The systems preferably include one or more of theintroducer, a treatment device, a tissue removal device, a subsonictreatment device, a drug delivery device, a dilating device, avaginal-wall-crossing device, a scaffolding device, a volume occupyingdevice, a stabilizing device, a visualization apparatus and a navigationapparatus, all of the present invention, and other devices applicable togynecological procedures. The systems of the present invention aresimple to use, and provide reduced risks while enhancing outcomes.

Treatment Devices are provided which allow a clinician to perform,individually or in combination with additional devices, one or moregynecologic and urologic procedures. The treatment devices providedinclude but are not limited to: devices which remove, denature orotherwise treat undesired tissue; devices which modify the structure ofa vessel such as a fallopian tube or blood vessel occlusion device; drugdelivery devices; and other therapeutic or diagnostic devices. Thetreatment devices preferably include an elongate shaft, and the shaftmay include one or more internal lumens. The proximal end of the shaftmay include one or more access ports, such as fluid access ports anddevice entry ports. A handle may be included on the proximal end, thehandle including one or more controls such as buttons, knobs or leversused to manipulate the elongate shaft or activate a mechanical orelectronic module of the device. The treatment devices of the presentinvention may additionally or alternatively perform a diagnosticfunction. These treatment devices may provide multiple functions, suchas diagnostic or treatment functions including applying a tamponadeforce to bleeding tissue or distending tissue such as uteral walltissue.

Treatment devices include tissue removal devices which can be insertedthrough the introducer of the present invention and be subsequentlyoperated to remove tissue. Tissue removal device are often arranged withvacuum assemblies which provide a vacuum proximate a tissue removalelement and evacuate the tissue to be removed to a site outside of thepatient's body.

Treatment devices include subsonic treatment devices which also can beinserted through the introducer of the present invention andsubsequently deliver subsonic energy to disrupt or otherwise modifytissue such as a fibroid.

Treatment devices include drug delivery devices which can be placed intothe patient and controllably deliver a drug to a specific area of tissueor space, such as the vaginal wall, cervix, uterus, uteral wall orfallopian tube as well as a specific fibroid, polyp, tumor or othertissue mass. These drug delivery devices may provide additionalfunctions, such as diagnostic or treatment functions including applyinga tamponade force to bleeding tissue or distending tissue such as uteralwall tissue.

Dilating devices are provided which can be used to dilate the cervix, apenetration tract in the vaginal wall, or other tissue. The dilatingdevices preferably include an elongate shaft, and the shaft may includeone or more internal lumens. The proximal end of the shaft may includeone or more access ports, such as fluid access ports and device entryports. A handle may be included on the proximal end, the handleincluding one or more controls such as buttons, knobs or levers used tomanipulate the elongate shaft or activate a mechanical or electronicmodule of the device. Specific embodiments include “smart” dilationsystems and methods which measure one or more parameters (e.g. deviceparameters such as strain or pressure or patient parameters such as EKG,EEG, blood pressure or respiration). One or more algorithms are appliedto the measured parameters and used to control one or more dilationparameters such as rate, force and magnitude. These dilation devices maybe integrated into another device, such as an introducer, a treatmentdevice, or other device of the present invention. These dilation devicesmay provide additional or alternative functions, such as diagnostic ortreatment functions including applying a tamponade force to bleedingtissue, distending tissue such as uteral wall tissue, or delivering adrug to tissue. The dilating devices of the present invention aretypically configured to dilate to a diameter less than 9 mm, preferablybetween 5 and 8 mm, and more preferably between 2 and 5 mm. The dilatingdevices of the present invention are typically dilated to a pressure notto exceed 300 psi (e.g. balloon dilation pressure), and preferably lessthan 150 psi.

Vaginal-wall-crossing devices are provided that permit safe introductionof one or more devices, such as the introducer of the present invention,from inside the vaginal canal, through the vaginal wall to variousanatomical locations including but not limited to: the outer wall of theuterus; the outer wall of the fallopian tubes; the ovaries;intra-abdominal locations; other locations and combinations thereof. Thecrossing devices preferably include an elongate shaft, and the shaft mayinclude one or more internal lumens. The proximal end of the shaft mayinclude one or more access ports, such as fluid access ports and deviceentry ports. A handle may be included on the proximal end, the handleincluding one or more controls such as buttons, knobs or levers used tomanipulate the elongate shaft or activate a mechanical or electronicmodule of the device. In a preferred embodiment, a guidewire is firstplaced through the vaginal wall, and one or more devices are placedover-the-wire. These crossing devices may provide additional oralternative functions, such as diagnostic or treatment functionsincluding delivering a drug to tissue.

Distension devices are provided which can be introduced into a space,such as the uterus, and apply a force to tissue. The distension devicesinclude without limitation, for example, scaffolding devices or thelike. The distension devices are preferably inserted through theintroducer of the present invention. The distension devices preferablyinclude an elongate shaft, and the shaft may include one or moreinternal lumens. The proximal end of the shaft may include one or moreaccess ports, such as fluid access ports and device entry ports. Ahandle may be included on the proximal end, the handle including one ormore controls such as buttons, knobs or levers used to manipulate theelongate shaft or activate a mechanical or electronic module of thedevice. These distension devices may provide additional or alternativefunctions, such as diagnostic or treatment functions including applyinga tamponade force to bleeding tissue or delivering a drug to tissue.These distension devices are preferably inserted into the uterus of apatient such that the scaffolding assembly preferably distends theuteral cavity to a volume equivalent to that which would be attained viaa liquid distension media at a pressure of at least 40 mm of HG but notgreater than 100 mm HG and preferably approximating 70 mm Hg.

Volume Occupying devices are provided which can be introduced into aspace, such as the uterus, and occupy space within the uterus. Thevolume occupying devices are preferably inserted through the introducerof the present invention. The volume occupying devices preferablyinclude an elongate shaft, and the shaft may include one or moreinternal lumens. The proximal end of the shaft may include one or moreaccess ports, such as fluid access ports and device entry ports. Ahandle may be included on the proximal end, the handle including one ormore controls such as buttons, knobs or levers used to manipulate theelongate shaft or activate a mechanical or electronic module of thedevice. These volume occupying devices provide the function of taking upspace in a cavity, such as taking up space in the uterus to reduce theamount of fluid delivered to the uterus in a diagnostic or therapeuticprocedure. These volume occupying devices may provide additional oralternative functions, such as diagnostic or treatment functionsincluding applying a tamponade force to bleeding tissue, distendingtissue such as uteral wall tissue, or delivering a drug to tissue.

Stabilizing devices are provided which are used to stabilize one or moreseparate devices, such as a treatment device of the present invention.Stabilizing devices may include magnets which attract a correspondingmagnet integral to the separate device such as to position a treatmentdevice proximate to tissue to be treated. The stabilizing devicespreferably include an elongate shaft, and the shaft may include one ormore internal lumens. The proximal end of the shaft may include one ormore access ports, such as fluid access ports and device entry ports. Ahandle may be included on the proximal end, the handle including one ormore controls such as buttons, knobs or levers used to manipulate theelongate shaft or activate a mechanical or electronic module of thedevice such as an electromagnet located in the distal portion of theshaft. These stabilizing devices may provide additional or alternativefunctions, such as diagnostic or treatment functions including applyinga tamponade force to bleeding tissue, distending tissue such as uteralwall tissue, or delivering a drug to tissue.

Visualization apparatus are provided which provide enhanced imaging oftarget anatomical locations within the patient. The apparatus includeone or more of: miniaturized cameras; infrared cameras; deployable lightsources; stabilizing mechanisms; image stabilizing modules andprocessing; and improved and cost-reduced displays (e.g. a laptop screendisplay). The visualization apparatus preferably include one or moredevices comprising an elongate shaft, and the shaft may include one ormore internal lumens. The proximal end of the shaft may include one ormore access ports, such as fluid access ports and device entry ports. Ahandle may be included on the proximal end, the handle including one ormore controls such as buttons, knobs or levers used to manipulate theelongate shaft or activate a mechanical or electronic module of thedevice. These visualization apparatus may provide additional oralternative functions, such as diagnostic or treatment functionsincluding applying a tamponade force to bleeding tissue, distendingtissue such as uteral wall tissue, or delivering a drug to tissue.

Navigating apparatus are provided which enable a clinician to navigateone or more diagnostic or therapeutic devices to perform a gynecologicprocedure. The navigation apparatus preferably include one or more of:an electromagnetic (EM) beacon and/or receiver; a light emitter and/ordetector; and a magnetic source and/or a detector. The navigationapparatus preferably include one or more devices comprising an elongateshaft, and the shaft may include one or more internal lumens. Theproximal end of the shaft may include one or more access ports, such asfluid access ports and device entry ports. A handle may be included onthe proximal end, the handle including one or more controls such asbuttons, knobs or levers used to manipulate the elongate shaft oractivate a mechanical or electronic module of the device. Thesenavigation apparatus may provide additional or alternative functions,such as diagnostic or treatment functions including applying a tamponadeforce to bleeding tissue, distending tissue such as uteral wall tissue,or delivering a drug to tissue.

Shape-modifying wires are provided which are slidingly received by oneor more lumens of a device of the present invention, such as amorcellating or other treatment device used to access and treat afibroid. Shapes on the one or more shaping wires can bias the elongateshaft of the device, such as at a distal portion, to a pre-determinedshape. In a preferred embodiment, multiple shaping wires with variedshapes are provided to accommodate different procedures and/or access todifferent anatomical locations.

Numerous devices of the present invention include an elongate shaft,similar in construction to shafts used in laparoscopic and percutaneousdevices. The shafts may be manufactured in a “lay up” process includingmultiple layers of similar or dissimilar materials, such as layers offlexible biocompatible material separated by a braided material such asmetal wire or plastic filament. The construction is chosen to provideadequate column strength and torqueability to access the desiredanatomical locations and perform the desired actions. Each shaftpreferably has a blunt or otherwise atraumatic distal tip. The shaftsmay include one or more lumens, such as a lumen configured to slidinglyreceive an elongate device such as a treatment catheter or guidewire, alumen configured to allow fluid delivery and/or fluid sampling orremoval; an inflation lumen configured to allow inflation of a balloon;a mechanical linkage lumen configured to slidingly receive a cable suchas to transmit force through the shaft (e.g. from a lever on a handle onthe proximal end of the shaft); a lumen configured to slidingly receivea shaping wire of the present invention; other lumens and combinationsthereof.

The elongate shafts of the present invention may include a reinforcedsection such as a section located at the portion of the shaft that, wheninserted into the body, is in proximity to the cervix. The reinforcedsection can provide the function of preventing collapse of an internallumen of the shaft (enhanced radial strength) as well as preventundesired perforation out of the shaft and into tissue such as cervicaltissue. The reinforced section may comprise the braiding processdescribed hereabove, and may be provided along a majority of length ofthe shaft, or a small portion. The shaft may include variable stiffnessalong its length, and may allow the stiffness to be adjusted, such asthrough the insertion of a stiffening wire, or by pressurizing aninternal (blind) lumen of the shaft. The shaft may include along itslength one or more clinician inflatable balloons, such as compliant ornon-compliant nylon or PET balloons configured to dilate, deflect thedevice or neighboring tissue; deliver a drug; or perform anotherfunction. The elongate shafts of the present invention are typicallyless than 9 mm in diameter, and preferably between 5 to 8 mm indiameter, and more preferably between 2 and 5 mm in diameter.

The elongate shafts of the present invention may include cliniciancontrolled deflection means, preferably one or more pull wires attachedat their proximal end to a control in a handle on the proximal end ofthe shaft, and attached on their distal end to a portion of the shaft,such as a distal portion of the shaft. Advancement and retraction of thepull wire causes a portion of the shaft to deflect, such as to bring atreatment element of the present invention in proximity to tissue to betreated. The shafts may further include one or more internal conduits,such as wires or optical fibers which do not need to be advanced orretracted. These conduits may be embedded in the wall of the shaft,fixed to an internal lumen, or sandwiched between to layers present in alayered construction. Wires can be used to transmit electrical signalsor energy, in either direction in the shaft. Fiber optic cables can beused to transmit light energy (e.g. laser energy) or signals (e.g.images from a lens), in either direction in the shaft. In the preferredembodiment, the shafts of the present invention include a handle ontheir proximal end, and the handle includes on or more controls toactivate one or more portions of the device. In another preferredembodiment, a “kill-switch” control is included to allow the clinicianto quickly stop an ongoing action.

The shafts and other components of the devices of the present inventionare constructed of biocompatible materials. The devices may beconfigured for one-time use or be resterilizable. The materials includemedical grade metals, plastics and other materials. Shaped memory metalssuch as Nitinol and shaped memory polymers may be used to providecontrollable material properties or meet specific elasticity and/orresiliency requirements. The shafts and other components may include oneor more coatings, such as coatings selected from the group consistingof: anti-infective drugs, anti-thrombogenic drugs; clotting agents;chemotherapeutics; anesthetics such as lidocaine; other drugs; andcombinations thereof. Alternatively, the shafts and other components mayinclude drug delivery means, such as drug reservoirs (e.g. connected toa supply of drug internal or external to the device) or drug depots(e.g. containing a supply of drug) One or more markers may be integralto a component of the device, such as a marker selected from the groupconsisting of: visible and non-visible markers; radiopaque markers;magnetic markers; ultrasonically reflective markers; and combinationsthereof.

A functional element may be mounted to the shafts or other components ofthe devices of the present invention. These functional elements mayinclude a sensor or transducer and/or another functional element such asa camera or marker as described hereabove. Applicable sensors includebut are not limited to: electrodes such as electrical mappingelectrodes; temperature sensors; pressure sensors; strain gauges;accelerometers; force sensing resistors; position sensors such as linearor rotary encoders; magnetic sensors such as hall effect transistors;optical sensors such as phototransistors; physiologic sensors such asEKG; EEG; respiration; blood sensors such as a blood gas sensors such asan O2 saturation sensors; glucose sensors; blood pressure sensors; pHsensors; other physiologic sensors; and combinations thereof. Applicabletransducers include but are not limited to: magnets; electrodes such asradiofrequency electrodes; heat generators; cryogenic generators; forceor space-occupying generators such as an expandable balloon or solenoid;drug delivery elements such as iontophoretic elements; sound transducerssuch as acoustic transducers, ultrasound transducers and subsonictransducers; radiation sources; light sources such as visible orinfrared light sources configured to provide a beacon for navigation andultraviolet light sources configured to treat infection or killbacteria; visualization elements such as cameras, lenses, fiber opticsand ultrasound crystals; other functional elements; and combinationsthereof. Functional elements may further include elements to causedissection of tissue, such as blunt dissection projections and fluidjets.

The systems, methods, apparatus and devices of the present invention areapplicable to patients with one or more of the following conditions:

presence of fibroids, polyps, tumors, blood clots or other undesiredtissue (e.g. fibroids attached to the wall of the uterus, in the uteralwall or on the outside of the uterus);

endometriosis and other abnormal bleeding;

uteral prolapse;

ectopic pregnancy;

fertility issues (e.g. inability to conceive or desire to avoidpregnancy);

cancer such as carcinoma of the cervix or uterus;

infection;

pain;

and other disorders.

The systems, methods, apparatus and devices of the present invention areapplicable to performing one or more therapeutic or diagnosticgynecologic and urologic procedures. These procedures may be performedinside or outside the uterus. Applicable primary procedures include butare not limited to:

fibroid, poly, tumor, blood clot, biopsy and other tissue removal,treatment or denaturing (e.g. removal, treatment or denaturing viamechanical means such as cutting, morcellating, lysing, excising orscraping; ablation such as radiofrequency, laser or cryogenic ablation;and/or removal of blood supply such as via associated vascularocclusion);

fertility procedures (e.g. in-vivo fertilization; tubal opening; eggharvesting and sperm delivery);

sterilization procedures (e.g. fallopian tube occlusion such as internalor external occlusion of the fallopian tube; procedures which detectand/or confirm fallopian tube occlusion; and fallopian tube removal orpartial removal);

endometrial ablation or resection (e.g. providing a tamponade force;delivering a clotting or other agent; delivering a fluid such as a fluidat an elevated temperature; providing ablation energy such asradiofrequency; ultrasonic, laser or cryogenic energy);

vascular modification (e.g. procedures that change blood flow such asflow reducing or increasing procedures including vascular stenting andocclusion)

intra-abdominal procedures (e.g. oophorectomy; tubal ligation; tubalresection; endometrial ablation; subserosal fibroid removal and ovariancyst removal) and

drug delivery (e.g. delivery of anesthetics; clotting agents;chemotherapeutics;

occlusive agents, bulking agents and other agents).

In the performance of one or more gynecologic and urologic procedures,such as one or more of the procedures listed above, the systems,methods, apparatus and devices of the present invention may be used toperform one or more additional procedures, including but not limited to:

mechanical or gel distension of organs (e.g. bladder, lung, stomach,bowel, esophagus, oral cavity, rectum, nasal sinus, Eustachian tubes,heart, gall bladder, artery, vein, ducts)

administering of anesthetics (e.g. lidocaine injections proximate thecervix, vaginal wall or other tissue; and injections to otherwise reducepain associated with cervical dilation; fallopian tube manipulation andvaginal wall penetration)

administering of a muscle relaxant, cervical pre-dilation and softening(e.g. a procedure performed a day or more in advance of a subsequentgynecological procedure)

dilation (e.g. cervical dilation and dilation of a penetration tractthrough the vaginal wall)

tissue dissection (e.g. blunt dissection; liquid-jet (e.g. saline)dissection; and energy assisted dissection; and dissection utilizingTumescent solution comprising an anesthetic such as lidocaine and avasoconstrictor such as epinephrine in order to dissect along normalfacial planes and reduce nerve damage)

vaginal wall and other conduit or organ penetration (e.g. penetrationcomprising an penetrating needle and guidewire passed through theneedle)

vessel occlusion or constriction (e.g. occlusion or constriction of ablood vessel such as the uteral artery; a fallopian tube; or theurethra)

implant delivery (e.g. an occlusive device such as occlusiveintra-luminal material or a vessel clip; a drug delivery implant such asa drug-loaded gel or foam; a radioactive seed; or suture)

radiation treatment (e.g. temporary or permanent implantation of aradioactive seed or other source of radiation such as a liquidradionucleotide)

delivery of energy (e.g. electromagnetic energy such as radiofrequencyenergy; chemical energy; heat or cooling energy; mechanical energy suchas vibrational energy; sound energy such as subsonic, acoustic andultrasound energies; radiation; and combinations thereof)

visualization of internal anatomy (e.g. via an endoscope or a camera orlens integral to a device shaft) and

guidance of one or more devices (e.g. via a visible beacon such as alight emitted from the uterus, fallopian tubes or other anatomicallocation or via an electromagnetic beacon such as an antenna receiving ahigh frequency signal).

The systems, methods, apparatus and devices of the present invention mayprovide and/or utilize various means and routes of access to an internallocation within the patient. Routes of access include but are notlimited to:

trans-cervical (defined above);

trans-vaginal-wall (defined above);

trans-uteral (defined above);

trans-vesicle;

trans-urethral;

laparoscopic, and other routes.

The devices and apparatus of the present invention may comprise anelongate shaft that includes one or more lumens such as to slidinglyreceive one or more separate devices also comprising an elongate shaft.The device lumens may be configured to support over-the-wire insertionover a standard guidewire, or alternatively a side-car mounted near thedistal end of the shaft may be provided to support monorail (also knownas rapid exchange) insertion. The device lumens, such as the introducerof the present invention, may be sized and be otherwise configured toslidingly receive one or more devices including but not limited to:

treatment device, tissue removal device, subsonic treatment device, drugdelivery device, scaffolding device, volume occupying device,stabilizing device, visualization apparatus and navigation apparatus, ashape-modifying wire; all of the present invention;

ablation device;

ligating, lysing and/or excising device;

tissue removing device (e.g. a morcellator; scraper; cutter; orgrabber);

tissue cutting device (e.g. an advancable blade cutting device);

tissue dissector (e.g. a blunt dissector; a fluid-jet dissector; or anenergy delivery dissector);

suture and knot tying device;

snaring device (e.g. a device used to snare a guidewire or blood clot);

visualization device (e.g. a hysteroscope or other endoscope);

navigation device;

drug delivery device (e.g. a iontophoresis catheter); and

vaginal crossing device (e.g. a needle based device which places aguidewire from inside the vaginal canal and through the vaginal wall).

The device lumens may be sized and include access elements such as luerfittings to attach to drug delivery devices such as syringes andinfusion pumps. The device elongate shaft may be sized and otherwiseconfigured to be passed through one or more devices including but notlimited to:

dilators (e.g. sequential dilators or balloon dilators), and

sheaths and introducers

Reference will now be made in detail to the present embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

Referring now to FIG. 1, a preferred embodiment of an introducerconsistent with an embodiment of the present invention is illustrated.As shown in FIG. 1, introducer 100 a includes an elongate, hollow shaft,sheath 110, which is configured to have distal end 111 (preferably withan atraumatic leading edge) be inserted into the body of a patient, suchas through the cervix and into the uterus, to provide a working channelto introduce tools through a lumen of sheath 110 and into the uterus. Inan alternative embodiment, distal end 111 of sheath 110 is placed intothe vaginal opening of a patient, and manipulated to penetrate throughthe vaginal wall (such as by advancing over a pre-existing guidewirepenetrating the vaginal wall), such as to provide a working channel tointroduce tools through a lumen of sheath 110 to a location outside theuterus. Sheath 110 may be configured to slidingly receive two or moredevices, independently or simultaneously. In an alternative embodiment,sheath 110 includes multiple lumens along its length, each lumenconfigured to slidingly receive a separate device. Sheath 110 may remainin place throughout the subsequent procedure, or for a portion of theprocedural steps. Sheath 110 may be repositioned during the procedure,such as to advance or withdraw sheath 110.

Sheath 110 is manufactured from medical-grade plastics, metals and otherbiocompatible material such as a sheath including a Teflon outer layer.One or more portions of sheath 110 may be radiopaque, such as byinclusion of a barium sulfate in plastic material or inclusion of one ormore metal portions which provide sufficient radiopacity. In a preferredembodiment, distal end 111 includes a radiopaque marker. Sheath 110 ispreferably of a braided construction as has been described hereabove,and includes a reinforced portion, reinforcement 115 (e.g. consisting ofa metal or plastic braided patch or embedded tube as has been describedhereabove) near its distal end, configured to maintain the patency ofone or more lumens within sheath 110 when external pressure is exerted(e.g. cervical or vaginal wall pressure) on that portion of sheath 110.Alternatively or additionally, reinforcement 115 may be configured toprevent a device inserted into sheath 110 from inadvertently puncturingout the side of sheath 110, such as to prevent a puncture that woulddamage cervical or other patient tissue unexpectedly. On the proximalend of sheath 110 is device insertion port 120, which provides access toan internal lumen of sheath 110 and has been configured to maintainfluid stasis with or without a device inserted through it. Port 120preferably has an “X” cut opening through one or more diaphragms thatmaintain that fluid seal. The thicknesses of the diaphragms and thematerials chosen preferably maintain pressure up to a predeterminedlevel (e.g. 50 mm Hg) after which fluid is automatically evacuated toprevent damage to the patient's internal tissue.

Mechanically attached and in fluid communication with device insertionport 120 are input valve 121 and output valve 122, each of whichincludes a standard luer connector for attachment to standard fluidinfusion lines. Input valve 121 and output valve 122 may include simpleone-way valves or more sophisticated valves that open (in eitherdirection or both) at pre-determined pressures. In combination with port120, fluid infusion and fluid evacuation means (not shown but preferablygravity driven or pump driven fluid movement means), can be attached toport 121 and port 122 and control the level of fluid introduced into thepatient via introducer 100 a. In a preferred embodiment, sheath 110 is asingle lumen and the fluid is introduced through that lumen. In analternative embodiment, sheath 110 includes multiple lumens and fluidcan be delivered or evacuated through one or more lumens, simultaneouslyor independently. In the various gynecological procedures describedherein, a volume of liquid and level of liquid pressure are used tovisualize the internal space and/or provide space to manipulate one ormore devices. In an alternative embodiment, a gel or gas is deliveredinto the patient.

Introducer 100 a may include a handle, not shown, on its proximal end.The handle may include one or more controls, as has been describedhereabove. Sheath 110 may include one or more valves within one or morelumens of sheath 110, such as a valve near the distal end 111.Introducer 1 00 a may include a balloon along sheath 110, such as aballoon configured to dilate tissue such as the cervix or the vaginalwall. In an alternative embodiment, multiple balloons are employed, suchas a balloon on a balloon configuration. Each balloon integrated intosheath 110 may have an integrally mounted functional element, as hasbeen described hereabove but preferably a pressure or force sensor usedto provide information to the clinician or a system component regardingdilation conditions (reference FIG. 13 herebelow). Sheath 110 mayinclude one or more functional elements along its length, such as avibrational transducer configured to assist in dilation. Sheath 110 mayinclude a lumen for insertion of a shaped wire, such as a wireconfigured to resiliently bias sheath 110 and/or a wire configured toplace a “straightening” bias on the cervical canal during introducerinsertion, once inserted or both. In another alternative embodiment,sheath 110 includes an expandable cage structure, not shown butprotruding from distal end 111. The expandable cage structure may have afluted geometry such as a geometry configured to follow the contour ofthe uterus when introducer 100 a is inserted through the cervix.

Introducer 100 of FIG. 1 and the numerous embodiments of the introducersdescribed throughout this application, are sized to accommodate the oneor more devices placed through sheath 110, while remaining as small aspossible to reduce tissue trauma and pain to the patient, especiallywhen sheath 110 is placed through the cervix of a patient. In a firstembodiment, sheath 110 of Introducer 100 is typically less than 9 mm indiameter and preferably less than 8 mm diameter. In another embodiment,sheath 110 is less than 7 mm in diameter. In another embodiment, sheath110 is less than 6 mm in diameter. In another embodiment, sheath 110 isless than 5 mm in diameter. In another embodiment, sheath 110 is lessthan 4 mm in diameter. In another embodiment, sheath 110 is less than 3mm in diameter. In another embodiment, sheath 110 is less than 2 mm indiameter. Sheath 110 is configured in size and rigidity to preventpainful and potentially destructive dilation of the cervix.

Referring now to FIG. 1A, another preferred embodiment of an introducerconsistent with the present invention is illustrated. Introducer 100 bhas a dual balloon construction and includes sheath 110, of similarconstruction to sheath 110 of FIG. 1. Introducer 100 b is shown over aguidewire 131, such as an 0.038″ standard interventional guidewire,which has been advanced through vagina V, through cervix C and intouterus U. An inflatable balloon introducer assembly 150 includes balloon151 and shaft 150 and is shown having been advanced into the cervix C ofa patient and balloon 151 inflated (inflation lumen and inflation portnot shown). Inflation of balloon 151 is used to pre-dilate cervix C suchthat sheath 110 can be advanced into cervix C. Inflation balloon 151 ispreferably less than 9 mm in diameter when fully inflated, and morepreferably between 2 and 8 mm in diameter. Shaft 155, which is slidinglyreceived by sheath 110, may be pulled back prior to advancement ofsheath 110, or balloon 151 may be left in place, although preferablypartially deflated prior to advancement. In an alternative embodiment,balloon assembly 150 including shaft 155 and balloon 151 may beconfigured to be completely removed from sheath 110 such as after sheath110 is placed to its desired location in the patient's body. Afteradvancement of sheath 110, further dilation of the cervix may beaccomplished by subsequent inflation of balloon 151, and/or viainflation of a balloon integral to sheath 110, balloon 116 (inflationlumen and inflation port also not shown). Inflation of either balloon151 or balloon 116, or both, may be used to anchor sheath 110 in place.

On the proximal end of sheath 110 is device insertion port 120, whichprovides access to an internal lumen of sheath 110 and is in fluidcommunication with fluid transfer port 123 configured to introduceand/or remove fluid or other media through sheath 110 and into thepatient as has been described hereabove. Port 120 includes a rotatingcollar 124, which can be rotated to permit devices to pass through port120 as well as seal around those devices, such as via a diaphragm whichseals around inserted devices similar to a Tuohy Borst valveconfiguration. Port 120 further provides fluid stasis when no device isinserted through it.

Guidewire 131 may be replaced with a different guidewire, such as with aguidewire with different stiffness or lubricious properties. Guidewire131 may remain in place for a majority of the procedure, or may beremoved early on.

Referring now to FIG. 1B, another preferred embodiment of an introducerconsistent with the present invention is illustrated. Introducer 1 00cincludes sheath 110 with distal end 111, device insertion port 120 withrotating collar 124 and fluid transfer port 123, all of similarconstruction to similar components of introducer 100 a of FIG. 1 andintroducer 100b of FIG. 2. Introducer 100 c has been placed overguidewire 141 and advanced such that its distal portion resides withincervix C and its distal end is within uterus U of a patient.

Introducer 100 c includes a force measuring element, strain gauge 113,which is used to monitor forces exerted on sheath 110 (and thecorresponding resultant forces exerted on the neighboring tissue).Wires, not shown but attached to strain gauge 113 and travelingproximally through sheath 110, attach to an electronic module, also notshown, and provide pressure or other force information to the clinicianor a system component which processes the information.

Introducer 100 c further includes drug delivery element 114, such as adrug delivery mechanism. Drug delivery element 114 may be a simple drugcoating, or may be a depot that stores a drug such as an anesthetic anddelivers the drug via osmosis, iontophoresis or other drug deliverymechanism. In a preferred embodiment, drug delivery element 114 is apressure releasable sack, such as a sack with a duck bill valve, andwhen sufficient pressure is applied to the sac, such as via the cervix,a drug, such as lidocaine, is delivered. In another preferredembodiment, drug delivery element 114 includes multiple pressure-drivensacks, such as multiple sacks in different locations and/or multiplesacks with different delivery pressure properties.

Introducer 100 c further includes a visualization apparatus,visualization element 112 preferably a forward looking visualizationtool such as forward looking ultrasound, or a lens that provides animage to a camera, not shown, but preferably a camera system thatreceives an image from a fiber optic in optical communication with thelens. A display, not shown but preferably integrated into a laptopcomputer via a USB or video connection, provides the camera image to theclinician and/or patient.

Referring now to FIG. 2, a preferred embodiment of a system 10consistent with the present invention is illustrated. System 10 includesintroducer 100 d and tissue removal device 200 which includes anintegral visualization apparatus, camera 256 mounted to side-saddlecatheter 250. Introducer 100 d includes sheath 110, device insertionport 120 and fluid transfer port 123, all of similar construction tosimilar components of introducers 100 a, 100 b and 100 c hereabove.Introducer 100 d has been placed and advanced such that its distalportion resides within cervix C and its distal end provides accesswithin uterus U of a patient. Sheath 110 includes a marker, radiopaquering 117 which can be used by the clinician to determine and/or confirmwith fluoroscopy the diameter (e.g. the inside diameter) of sheath 110at the location of ring 117, such as to confirm or rule out thecondition where the cervix may be undesirably compressing sheath 110. Inan alternative embodiment, ring 117 is an ultrasonically reflectivemarker enabling the condition to determine the associated diameter byusing ultrasound, such as via an ultrasound device commonly located in agynecologist office.

Tissue removal device 200, a morcellating device, has been advancedthrough port 120, through a lumen of sheath 110, and into the uterus Uof a patient. Tissue removal device 200 includes an elongate shaft, tube201, which includes on its distal end 203 a cutout, window 202. Acutting element 210 is present within window 202 such that as the distalend of tube 201 is manipulated near tissue, cutting element 210 will cutthat tissue. Vacuum means, not shown put in fluid communication with alumen of tube 201 and window 202, evacuate the pulverized, cut orotherwise detached particles to a location outside of the patient. In apreferred embodiment, vacuum and evacuation means are integral to ahandle of device 200. In another preferred embodiment, vacuum andevacuation means are connected to a port which is integral to a handleof device 200. Cutting element 210, of one or more configurations suchas the configurations described below in reference to FIGS. 2A and 2B,is preferably attached to a speed control mechanism, not shown. Thespeed control mechanism is simplified for use by including one or morefeedback means (e.g. electromotive feedback, rotation or other speedfeedback, vibrational feedback, physiologic feedback such as EKG orblood pressure, or other feedback), wherein the feedback means can beused to automatically control the speed, greatly simplifying use for theclinician. In a preferred embodiment, the clinician available feedbackis limited to a small number of finite settings, such as less than 10settings. In another preferred embodiment, a kill-switch is included ona handle of the device, which is readily accessible to the clinician andupon activation removes power and/or applies a breaking function toinstantaneously stop the cutting motion.

Referring additionally to FIG. 2C, also included in the system 10 ofFIG. 2 is a side-saddle catheter 250 which includes sleeve 252 (e.g. aTeflon sleeve) which slidingly surrounds tube 201. Advancement andretraction of an elongate shaft, shaft 205 causes a visualizationapparatus, camera 255 to be correspondingly advanced and retractedrelative to tube 201. The image received from camera 255, such as animage displayed on a laptop computer display as has been describedhereabove, is used by the clinician to position the window 202 of tissueremoval device 200 near one or more fibroids, such as fibroid F1 locatedwithin the wall of uterus U and fibroid F2 attached to the wall ofuterus U. Camera 225 may utilize CCD and/or MEMS mirror controltechnology to produce and/or transfer an image. In a preferredembodiment, camera 225 includes one or more motion sensing elements,such as miniaturized accelerometers or gyros which can be fed back to animage processing system, not shown but preferably external to thepatient, such that the image provided to the clinician does not move asthe camera is moved. Alternatively or additionally, side saddle catheter250 includes one or more functional elements, not shown but preferablyselected from the list of functional elements provided hereabove. Thefunctional element may be a fluid delivery port, such as a portconfigured to deliver saline or other clear fluid to clear the pathwayof the camera view or to clean off a contaminated lens.

Referring now to FIG. 2A, a preferred embodiment of the cutting element210 of FIG. 2 is shown. The distal end of tube 201 and window 202 isshown with an oscillating cutter 211 attached to an elongate controllinkage, shaft 221, which is attached at its proximal end to areciprocating motor assembly, not shown, but preferably a simplified,precision speed controlled assembly as has been described hereabove. Ina preferred embodiment, the speed assembly utilizes feedback, also ashas been described hereabove. Referring now to FIG. 2B, anotherpreferred embodiment of the cutting element of FIG. 2 is shown. Thedistal end of tube 201 and window 202 is shown with an spinning orrotational cutter 212 attached to an elongate control linkage, shaft221, which is attached at its proximal end to a rotational motorassembly, not shown, but preferably a simplified, precision speedcontrolled assembly as has been described hereabove. In a preferredembodiment, the speed assembly utilizes feedback, also as has beendescribed hereabove.

System 10 of FIG. 2 is configured such that the outer diameter of sheath110 of introducer 100 d is minimized. Inserted devices such as tissueremoval device 200 (including camera 256) and other inserted devices arealso minimized in the cross sectional profiles of their distal portions,such that the inner diameter (and thus the outer diameter) of sheath 110can be reduced. In a first embodiment, sheath 110 of Introducer 100 istypically less than 9 mm in diameter and preferably less than 8 mmdiameter. In another embodiment, sheath 110 is less than 7 mm indiameter. In another embodiment, sheath 110 is less than 6 mm indiameter. In another embodiment, sheath 110 is less than 5 mm indiameter. In another embodiment, sheath 110 is less than 4 mm indiameter. In another embodiment, sheath 110 is less than 3 mm indiameter. In another embodiment, sheath 110 is less than 2 mm indiameter. Sheath 110 is configured in size and rigidity to preventpainful and potentially destructive dilation of the cervix.

Referring now to FIG. 3, another preferred embodiment of a system 10consistent with the present invention is illustrated. System 10 includesintroducer 100 and subsonic treatment device 300. Introducer 100includes sheath 110, device insertion port 120 and fluid transfer port123, all of similar construction to similar components of introducers100 a, 100 b, 100 c and 100 d hereabove. Introducer 100 d has beenplaced and advanced such that its distal portion resides within cervix Cand its distal end provides access within uterus U of a patient. Atreatment catheter of the present invention, acoustic generator device300 has been inserted through port 120, down a lumen of sheath 110 andinto the uterus of the patient.

Referring additionally to FIG. 3A, acoustic generator device 300includes acoustic transducer 310 which comprises housing 302, preferablya metal can with a lumen 304, and a sound crystal 303, configured todeliver subsonic sound waves. System 10 preferably includes specializedfluid medium, which is injected into uterus U via port 123 and sheath110. The fluid medium is configured to adequately conduct the emittedsound waves and provide an impedance mismatch between it and thetargeted tissue (e.g. endometrium), such that large amounts of energy(sufficient to destroy or otherwise denature the tissue cells) istransferred to the tissue when the subsonic waves arrive at theinterface.

Referring now to FIG. 4, another preferred embodiment of an introducerconsistent with the present invention is illustrated. Introducer 100 eis configured to puncture through tissue, such as the vaginal wall toperform a trans-vaginal-wall procedure. Introducer 100 e includes sheath110 with balloon 116 and distal end 111, device insertion port 120 andfluid transfer port 123, all of similar construction to similarcomponents of introducer 100 a, 100 b, 100 c and 100 d hereabove.

Balloon 116, which can be configured to perform one or more functionssuch as to dilate tissue, to anchor sheath 110 in place and to maintainone or more lumens of sheath 110 in an open state under high loadingconditions. Balloon 116 is in fluid communication with inflation lumen152 and injection port 153 such that a syringe or endoflator attached tothe luer of port 153 can be used to inflate balloon 116. Balloon 116includes a miniaturized, integral pressure sensor 154, which ispreferably attached to one or more wires, not shown but travelingproximally and attaching to an electronic module which processes thereceived signal and provides pressure information to the clinicianand/or utilizes the information in one or more ways such as to reducepatient pain such as via the “smart” dilation system and methoddescribed in detail in reference to FIG. 13 herebelow. Additionalballoons and/or pressure sensors may be integrated into sheath 110.

Pull wire 171 is fixedly attached at its distal end to a distal portionof sheath 110, and it is operably attached at its proximal end to knob172, such that rotation of knob 172 causes sheath 170 to deflect. Asshown in FIG. 4, rotation of knob 172 that causes pull wire 172 toretract causes the distal end of sheath 110 to deflect to the left androtation of knob 172 that causes pull wire 172 to advance causes sheath110 to deflect to the right. In an alternative embodiment, additionalone or more pull wires are included to allow a clinician to deflectsheath 110 in multiple directions at multiple points along the length ofsheath 110. Deflection of sheath 110 allows for directional orientation,positioning and advancement of the one or more treatment or otherdevices that can be inserted into sheath 110 via port 120 (inserteddevices not shown).

Introducer 100 e includes a tissue penetrating assembly comprisingneedle 161, an elongate hollow needle preferably constructed ofstainless steel or Nitinol, which has fixedly attached on its proximalend, knob 162. Needle 161 resides within a lumen of sheath 110, and isin place when introducer 100 e is advanced through tissue. Needle 161has an internal lumen sized to slidingly receive guidewire 131.Guidewire 131 can be placed trough needle 161 after needle 161 has beenadvanced through tissue (guidewire loaded from proximal end of needle161). Alternatively, guidewire 131 can be placed to a target location,such as through the vaginal wall of a patient via another needle device,and then passed through needle 161 (guidewire loaded from distal end ofneedle 161). In a preferred embodiment, needle 161 can be used todeliver anesthetic to tissue prior to needle 161 and/or sheath 110advancement.

Introducer 100 e may have one ore more functional elements, such as afunctional element described hereabove and integrated into sheath 110.In a preferred embodiment, a functional element comprising avisualization apparatus or a portion of a visualization apparatus, suchas a camera lens and fiber optic or an ultrasound crystal and associatedwiring are contained within sheath 110. Advancement of sheath 110 e,such as through the vaginal wall to a location neighboring the outsideof a patient's uterus, may require dissection of tissue. In a preferredembodiment, introducer 100 e includes a functional element such as ablunt dissector, a fluid jet, or other dissection element. In anotherpreferred embodiment, a blunt dissection device, such as a blunt tippedprobe, electrocautery probe, or fluid-jet probe, is advanced through alumen of sheath 110 prior to and/or during advancement of sheath 110through tissue. Once inserted into the body of the patient, the distalportion of sheath 110 may need to be tracked, such as it is advancedthrough the vaginal wall at the preferred location of the anterior orposterior culdesac of the vagina, to a location outside the uterus.Tracking means, such as visualization systems and navigation systems ofthe present invention, may be used such as by incorporating one or morevisualization or navigation elements in introducer 100 e and/or by usingseparate devices to navigate and/or visualize. In a preferredembodiment, a visible light source is placed in a fallopian tube and acamera integral to introducer 100 e or a device inserted through sheath110 is used to locate the visible light source and access the associatedfallopian tube. In another preferred embodiment, an electromagnetictransmitting antenna is placed in a fallopian tube and a receivingantenna is integral to introducer 100 e or a device inserted throughsheath 110 and is used to locate the transmitting source and access theassociated fallopian tube.

Referring now to FIG. 5, another preferred embodiment of a system 10consistent with the present invention is illustrated. System 10 includesintroducer 100 f and treatment catheter 500 a which includesvisualization element 520 and orientation apparatus 521. Introducer 100f includes sheath 110, device insertion port 120 and fluid transfer port123, all of similar construction to similar components of introducers100 a, 100 b, 100 c, 100 d and 100 e hereabove. Introducer 100 f hasbeen advanced through the vaginal opening into the vagina V of apatient, to a distal location of the vaginal canal, proximate the cervixC. Sheath 110 has exited through the vaginal wall, as was describedhereabove in reference to FIG. 4. A treatment or diagnostic device, ashave been described in detail hereabove, treatment catheter 500 a, hasbeen advanced through a lumen of sheath 110, and further advanced, suchas with manipulation via pull wires integral to introducer 100 f and/ortreatment catheter 500 a, neither pull wires shown, such that the distalend of treatment catheter 500 a is proximate a fibroid F located in thewall of uterus U.

Treatment catheter 500 a includes shaft 501, which includes near itsdistal end treatment element 510, such as a morcellating assembly, asubsonic generator, an excisor, a cutter, an ablation element, or othertissue removal or denaturing element as has been described in detailhereabove. Also located near the distal end of shaft 101 isvisualization element 520 which is preferably a camera lens connected toa fiber optic cable and configured to produce an image on display 525 oflaptop 526 via a cable, wire bundle 527. Alternatively, visualizationelement 520 is an ultrasound crystal or crystals such as a rotatingcrystal or phased array of crystals, configured to produce an image ondisplay 525 of laptop 526 via cable 527. Visualization element 520further includes orientation apparatus 521, a nanoscale mechanism, suchas a MEMS gyroscope, accelerometer or series of mercury switches, thatis configured to provide movement information to an image processingunit such that the image provided to the clinician does not move as thevisualization element moves. The image processing unit may be integralto laptop 526 and/or another component of system 10.

Shaft 501, which extends beyond the proximal end of introducer 100 f andexits port 120, preferably includes on its proximal end a handle withone or more clinician controls (e.g. on-off buttons, pull wirerotational knobs, etc) and/or connections such as electrical connectionsto laptop computer 526, or mechanical connections such as to motorassemblies which provide motion to visualization element 520 (e.g. to arotating ultrasound crystal) or treatment element 510 (e.g. to aspinning or reciprocating cutting blade).

Anesthetics, such as lidocaine, may be administered peri-procedurally(prior to, during and post procedure), via a separate device, or via oneor more functional elements of introducer 100 f. Numerous gynecologicalprocedures are applicable to the system 10 and method of FIG. 5,including but not limited to: intra-uteral procedures (re-enteringuterus thus avoiding cervical crossing); uteral wall procedures (e.g.the fibroid F treatment shown); fallopian tube procedures (e.g. tuballigation); ovary procedures (e.g. egg harvesting); cancer treatmentprocedures; pain treatment procedures; other tissue treatment or removalprocedures, and intra-abdominal procedures. As described in reference toFIG. 4, one or more blunt dissection procedures may be performed in theplacement of introducer 100 f and/or the advancement of one or moredevices (e.g. treatment catheter 500 a) through sheath 110 and to thetarget procedure location. Also as described in FIG. 4, one or morenavigation or visualization procedures or devices may be used tonavigate introducer 100 f and/or treatment catheter 500 a.

In an alternative embodiment, an additional device is inserted throughport 120 and sheath 110, either sequentially or simultaneously withtreatment catheter 500 a. The additional device may perform one or morefunctions such as that of a treatment device, navigation device,stabilizing device, visualization device or other device as has beendescribed as performing a function related to the intended gynecologicand urologic procedures described throughout this application. Inanother alternative embodiment, treatment catheter 500 a includes asecond treatment element, of similar or dissimilar functionality totreatment element 510.

Referring now to FIG. 5A, another preferred embodiment of a system 10consistent with the present invention is illustrated. System 10 includesintroducer 100 g, treatment catheter 500 b and stabilizing device 550.Introducer 100 g includes sheath 110, device insertion port 120 andfluid transfer port 123, all of similar construction to similarcomponents of introducers 100 a, 100 b, 100 c, 100 d, 100 e and 100 fhereabove. Introducer 100 g has been advanced through the vaginalopening into the vagina V of a patient, to a distal location of thevaginal canal, proximate the cervix C. Sheath 110 has exited through thevaginal wall, as was described hereabove in reference to FIG. 4. Sheath110 includes drug delivery element 114, located along sheath 110 at alocation proximate the intended vaginal wall crossing, such that one ormore drugs, preferably an anesthetic such as lidocaine, can be deliveredto reduce pain. Drug delivery element 114 may deliver a drug via simpleinfusion means such as osmosis or a weak-bonded coating transitioninginto solution, or more sophisticated means such as pressure-regulateddelivery or iontophoresis as has been described in detail hereabove.

A treatment or diagnostic device, as have been described in detailhereabove, treatment catheter 500 b, has been advanced through a lumenof sheath 110, and further advanced, such as with manipulation via pullwires integral to introducer 100 f and/or treatment catheter 500 b,neither pull wires shown, such that the distal end of treatment catheter500 b is proximate a fibroid F located in the wall of uterus U.Treatment catheter 500 b includes shaft 501, which includes near itsdistal end treatment element 510, such as a morcellating assembly, asubsonic generator, an excisor, a cutter, an ablation element, or othertissue removal or denaturing element as has been described in detailhereabove. Also located near the distal end of shaft 101 is magnet 502,such as a rare earth magnet or clinician activatable electromagnetconfigured to allow the distal portion of shaft 501 of catheter 502 tobe manipulated by one or more clinician-controllable magnetic fields.System 10 further includes stabilizing device 550, inserted into theuterus through the vagina V and cervix C of the patient (outside ofintroducer 100 g). At the distal end of shaft 551 of stabilizing device500 is a second magnet, magnet 552, preferably a rare earth magnet orclinician activatable electromagnet similar or dissimilar (such as adifference in size and/or magnetic field strength) to magnet 502 oftreatment catheter 550 b. Manipulation of the distal ends of either orboth stabilizing device 550 or treatment catheter 500 b such that magnet552 is in relative proximity to magnet 502 will enable the magneticforce to pull the two magnets and associated distal ends together. In apreferred embodiment, either or both magnet 552 and magnet 502 areelectromagnets such that one or both magnetic fields can be deactivatedfor initial manipulation(s), and activated to achieve final position,such as at a location where treatment element 510 is in close proximityto uteral fibroid F, as shown in FIG. 5A. In a preferred embodiment, themagnetically guided system 10 of FIG. 5 a can perform one or moreprocedures without the need for a camera or other visualizationapparatus. In an alternative embodiment, a camera or other visualizationapparatus is used, such as with a visualization element incorporatedinto sheath 100 g, treatment catheter 500 b or stabilizing device 550.

Shaft 501, which extends beyond the proximal end of introducer 100 g andexits port 120, and shaft 551 both preferably include on their proximalend a handle with one or more clinician controls (e.g. on-off buttons,pull wire rotational knobs, etc) and/or connections such as electricalconnections to a laptop computer (not shown but similar to laptopcomputer 526 of FIG. 5), or mechanical connections such as to motorassemblies which provide motion to treatment element 510 (e.g. to aspinning or reciprocating cutting blade) or to manipulate one or moreinternal pull wires such as to create a robotically manipulated system.

Referring now to FIG. 6, a preferred embodiment of a trans-fallopianmethod for performing a gynecologic procedure is illustrated. A firsttreatment device 500 c is inserted through the vaginal canal of thevagina V, through the cervix C, through the uterus U and through afallopian tube FT1 to a location outside the fallopian tube FT1. Firsttreatment device 500 c includes an elongate shaft, shaft 501 c whichincludes on its distal end occluding assembly 510 c, shown as a snaringassembly but alternatively an occluding clip placement assembly or anocclusive drug delivery assembly. Shaft 501 c preferably includes one ormore pull wires, for manipulation, and alternatively or additionally maybe advancable over a previously placed guidewire. Shaft 501 c preferablyincludes a handle on its proximal end, not shown but preferablyincluding one or more controls such as pull wire controls and a controlto synch up the snare of treatment element 510 c. Treatment element 510c is shown having snared a portion of fallopian tube FT1 such as toocclude fallopian tube FT1 in a sterilization procedure.

A second treatment device 500 d is inserted through the vaginal canal ofthe vagina V, through the cervix C, through the uterus U and through afallopian tube FT2 to a location outside the fallopian tube FT2 andproximate subserosal fibroid F. In an alternative embodiment, theintroducer of the present invention is placed into the cervix C, andfirst treatment device 500 c and/or second treatment device 500 d arepassed into the uterus U via the introducer. In another alternativeembodiment, one or more of the previous devices resides outside of theintroducer, such as to stabilize that device in the uterus. Secondtreatment device 500 d includes an elongate shaft, shaft 501 d whichincludes on its distal end treatment element 510 d, a fibroid treatingelement such as a morcellator, an ablative element, a lysing or excisingelement, or another device used to remove or denature fibroid tissue.Shaft 501 d preferably includes one or more pull wires, formanipulation, and alternatively or additionally may be advancable over apreviously placed guidewire. Shaft 501 d preferably includes a handle onits proximal end, not shown but preferably including one or morecontrols such as pull wire controls and a control to activate fibroidtreating element 510 d.

Treatment catheter 500 c and/or treatment catheter 500 dmay include oneor more functional elements as has been described in detail hereabove.Preferably, a navigation and/or visualization element is employed tointroduce the ends of the devices, especially to the target locationonce exiting the fallopian tube. Preferably treatment catheter 500 cand/or treatment catheter 500 d include one or more visualizationmarkers, such as visible and non-visible markers; radiopaque markers;magnetic markers; ultrasonically reflective markers; and combinationsthereof. Similar to the trans-vaginal-wall methods of FIGS. 5 and 5A,the trans-fallopian tube approach of FIG. 6 may be used to performnumerous procedures including but not limited to: uteral wall procedures(e.g. the fibroid F treatment shown); fallopian tube procedures (e.g.the tubal ligation shown); ovary procedures (e.g. egg harvesting);cancer treatment procedures; pain treatment procedures; other tissuetreatment or removal procedures, and intra-abdominal procedures.

Referring now to FIG. 7, a preferred embodiment of a drug deliverydevice of the present invention is illustrated. Drug delivery device 400is shown having been inserted into through the vagina V and into thecervix C of a patient. Device 400 includes an elongate shaft 401 with,near its distal end, drug delivery assembly 410. Drug delivery assembly410 includes needles 411 (e.g. Nitinol or stainless steel needles),shown deployed into the cervix C such as to deliver a drug to thecervix. Applicable drugs include anesthetics such as lidocaine, musclerelaxing drugs, and other drugs. Shaft 401 may include one or morelumens, such as a fluid delivery lumen to deliver a drug to needles 411and a guidewire lumen for preferably advancing shaft 401 into the cervixC over a guidewire.

Referring now to FIG. 7A, the distal end of shaft 401 is shown. Shaft401 surrounds inner shaft 406, which can be controllable advanced andretracted by the clinician such as via one or more controls on aproximal handle of drug delivery device 400, handle and controls notshown. Needles 411 are undeployed, contained within the wall of shaft401 with their distal tips oriented toward and proximate to exit holes412. Referring now to FIG. 7B, inner shaft 406 has been retracted,causing needles 411 to deploy, passing through exit holes 412. Suchretraction would cause needles 411 to penetrate into neighboring tissue,such as cervical tissue when shaft 401 is placed in the cervix wheninner shaft 406 is retracted. In order to support the intended motion,needles 411 may be flexible or may be connected to a flexible hinge.

Referring now to FIG. 7D, a preferred embodiment of a drug deliverydevice of the present invention is illustrated. Drug delivery device 400c is shown having been inserted into through the vagina V and into thecervix C of a patient. Device 400 c includes an elongate shaft 401 with,near its distal end, drug delivery assembly 410 d. Shaft 401 includesoccluding rings 416 on either end of drug delivery assembly 410 c.Occluding rings 416 and drug delivery assembly 410 c have beenpositioned in the cervix C such that drug delivered through one or moreexit holes 412 of drug delivery assembly 410 c will contact cervicaltissue. Applicable drugs include anesthetics such as lidocaine, musclerelaxing drugs, and other drugs.

Occluding rings 416 are sized to form a seal in the cervix, such as toallow elevated pressure delivery of drugs and/or to provide a vacuumseal in the area surrounding drug delivery element 410 c. In analternative embodiment, shaft 401 includes a single occluding ring 201,such as at a location of the proximal occlusion ring shown. In anotheralternative embodiment, occluding rings 201 may have a controllablediameter, such as rings comprising an inflatable balloon, ballooninflation lumen and inflation port not shown.

Drug delivery element 410 c further includes one or more suction ports414. Suction ports 414 and occluding rings 416 are configured such thatwhen a vacuum is applied to suction ports 414, the cervical (or otherneighboring) tissue is pulled toward the exit holes 412 of drug deliveryelement 410 c, such that the efficacy of drug delivered through exitholes 412 is enhanced. Exit holes 412 and suction ports 414 areconnected to independent hollow conduits that travel from drug deliveryelement 410 c to port 420 on the proximal end of drug delivery device400 c. Port 420 fluidly connects to drug reservoir 430, which in turn ispressurized by pressure reservoir 440 (such as a CO₂ pressure source)such that fluid can flow through shaft 401 to exit holes 412. Port 420is also fluidly connected to vacuum generator 450 such that suction canbe transferred through shaft 401 (in a separate conduit than isconnected to drug reservoir 430) to suction ports 414.

In an alternative embodiment, drug delivery element further includes aniontophoretic element, not shown but configured to enhance drug deliveryinto the tissue surrounding drug delivery element 410 c. In anotheralternative embodiment, shaft 401 includes a lumen to supportover-the-wire delivery.

Referring now to FIG. 8, another preferred embodiment of a drug deliverydevice of the present invention is illustrated. Drug delivery device 400a is shown having been inserted into through the vagina V and into thecervix C of a patient. Device 400 a includes an elongate shaft 401 whichincludes drug delivery assembly 410 a near its distal end. Drug deliveryassembly 410 a includes exit holes needles 413, sized and configured todeliver a drug to the cervix. Applicable drugs include anesthetics suchas lidocaine, muscle relaxing drugs, and other drugs. Shaft 401 mayinclude one or more lumens, such as a fluid delivery lumen to deliver adrug to exit holes 413 and a guidewire lumen for preferably advancingshaft 401 into the cervix C over a guidewire.

Referring now to FIG. 8A, the distal end of shaft 401 is shown. Shaft401 surrounds an occluding guidewire 402. Shaft 401 can be controllablyadvanced and retracted by the clinician over guidewire 402. Proximal toexit holes 413 is marker 404, preferably a radiopaque or ultrasonicallyreflective marker used to position the exit holes 413 in the cervix C.Referring now to FIG. 8B, the proximal end of inner shaft 406 is shownwherein guidewire 402 exits the proximal end of the device. Infusionport 403 provides fluid access to the exit holes 413 such that drugs canbe delivered via a syringe, infusion pump, or gravity feed system.

Referring now to FIG. 9, another preferred embodiment of a drug deliverydevice of the present invention is illustrated. Drug delivery device 400b is shown having been inserted into through the vagina V and into thecervix C of a patient. Device 400 a includes an elongate shaft 401 with,near its distal end, drug delivery assembly 410 b comprising a balloonwith multiple exit holes which are sized and configured to deliver adrug to the cervix. Applicable drugs include anesthetics such aslidocaine, muscle relaxing drugs, and other drugs. Shaft 401 may includeone or more lumens, such as a fluid delivery lumen to deliver a drug toexit holes 413 and a guidewire lumen for preferably advancing shaft 401into the cervix C over a guidewire.

Referring now to FIG. 9A, the distal end of shaft 401 is shown havingbeen inserted over guidewire 402. Shaft 401 can be controllably advancedand retracted by the clinician over guidewire 402. Drug deliveryassembly 410 b includes an inflatable balloon 415, preferably a dualballoon construction with exit holes 413 in the outer balloon. Referringnow to FIG. 9B, the proximal end of inner shaft 406 is shown whereinguidewire 402 exits the proximal end of the device. Infusion port 403provides fluid access to the exit holes 413 such that drugs can bedelivered via a syringe, infusion pump, or gravity feed system.Inflation port 406 provides inflation access to balloon 415, such as toan inner balloon portion of balloon 415. In an alternative embodiment,an enhanced drug delivery element is integral to balloon 415, such as aniontophoretic element for precision controlled drug delivery. In anotheralternative or additional embodiment, balloon 415 is inflated to dilateor partially dilate the cervix C of the patient.

Referring now to FIG. 10, a preferred embodiment of a scaffolding deviceof the present invention is illustrated. Scaffolding device 600, and theother distension devices of the present invention, are preferablyinserted into the uterus of a patient such that the scaffolding assemblypreferably distends the uteral cavity to a volume equivalent to thatwhich would be attained via a liquid distension media at a pressure ofat least 40 mm of HG but not greater than 100 mm HG and preferablyapproximating 70 mm Hg. Scaffolding device 600 is shown having beeninserted into through the vagina V, through the Cervix C and into theuterus U of a patient. In an alternative embodiment, the introducer ofthe present invention is placed into the cervix C, and scaffoldingdevice 600 is passed into the uterus U via the introducer. Scaffoldingdevice 600 includes elongate shaft 601. Extending beyond the distal tip602 of shaft 601 is deployable basket 611. Basket 611, shown in itsfully expanded state, is preferably a resiliently biased foldable weaveof filaments made of Nitinol. Manipulation of shaft 601 (e.g. viapull-wires not shown) and/or basket 611 can be performed by theclinician to exert forces against one or more portions of the uteralwall UW such as to distend or scaffold the uteral wall, to applytamponade to a bleed, and combinations thereof. Basket 611 can bearranged in numerous shapes, such as to mimic the shape of the uterus ora portion of the uterus. The weaved filaments may be sized (e.g.diameter, length or width) to effectively cover a small proportionalarea (e.g. large “windows” between filaments) or they may be configuredto cover a large proportion of the area (e.g. with a large profileand/or a covering).

Basket 611 may include a covering, on the inside or the outside of theresiliently biased structure, and the covering may be a partialcovering. In a preferred embodiment, a clinician places a tamponadeforce on a bleeding tissue location with a covered portion of basket611. In another preferred embodiment, a clinician reduces the amount offluid used in a procedure by inserting a scaffolding device 600 thatincludes a covering of basket 611 (i.e. the basket occupies space in theuterus and/or limits fluid transfer from the portion of the uteral wallin contact with the balloon). Basket 611 and any associated coveringsmay be coated, impregnated or otherwise include one or more drugs, suchas clotting agents and anesthetics. In a preferred embodiment, the drugmay be “released” by the clinician on demand, such as by an integraliontophoretic delivery element (e.g. integral to basket 611), or byapplying a force to an integral pressure activated drug depot (e.g.integral to basket 611). Basket 611 and any associated coverings may becoated or treated with one or more compounds to change a property suchas lubricity and radiopacity. Avoiding or reducing the need fordistension with fluid subsequently reduces the risk factors (e.g.intravasation) associated with that fluid delivery.

Referring now to FIG. 10A, a cross section of the distal portion ofscaffolding device 600 is shown with basket 611 in a near-fully deployedstate. Basket 611 is fixedly attached to control shaft 612 which isslidingly received by outer shaft 601 via lumen 603. The proximal end ofshaft 601 is preferably attached to a handle, not shown, which includesone or more controls, also not shown but preferably including a controlknob or lever that can precisely advance and retract control shaft 612.Retraction of control shaft 612 causes basket 611 to withdraw into thelumen 603 of shaft 601 and transition to a radially compact state.Subsequent advancement of control shaft 612 causes bases 611 to exitlumen 603 and resiliently expand into the deployed state shown if FIG.10. In an alternative embodiment, basket 611 includes mechanicalexpansion means to assist in radial expansion, such mechanical expansionmeans including an inflatable balloon inside or outside of basket 611,advancable push rods which exert radial forces upon different portionsof basket 611 and/or other mechanical means. In this alternativeembodiment, basket 611 may or may not be resiliently biased.

In a preferred embodiment, basket 611 can be expanded in the uterus (orother body cavity), and a procedure such as a tissue removal ordenaturing procedure be performed “through” the weave of basket 611.Numerous one or more treatment or other devices, can be used by theclinician while scaffolding device 600 is in place in the uterus. Inparticular, tissue treatment devices (e.g. morcellators; radiofrequency,laser and cryogenic ablaters; and subsonic treatment devices) and drugdelivery devices can perform their intended function, such as to treattissue present in between the filaments (tissue in “window) of basket611. In another preferred embodiment, scaffolding device 600 is used totreat uteral prolapse. In yet another preferred embodiment, a separateballoon catheter is inserted within balloon 611, such as to occupy spaceand/or apply additional force to the uteral wall. In yet anotheralternative embodiment, one or more portions of basket 611 can beenergized (e.g. deliver RF energy to tissue) in order to treat tissue,which may avoid the need for a second device.

Referring now to FIG. 10B, another preferred embodiment of a scaffoldingdevice of the present invention is illustrated. Located on the distalend of elongate shaft 601 is a deployable scaffolding assembly 610 a.Scaffolding assembly 610 a is configured to scaffold open a body cavitysuch as the uterus, while also providing an operating space to performone or more procedures such as tissue removal. Scaffolding assembly 610a make be arranged in one or more shapes, such as to conform to specificbody areas such as the contour of uteral wall. Scaffolding assembly 610a comprises two resiliently biased arms, first arm 621 and second arm622. These arms, preferably constructed of Nitinol, are configured to beradially compressed when drawn into the distal end of a tube, such asthe lumen of the introducer of the present invention (see FIG. 10D).Shaft 601 preferably includes one or more lumens, such as a lumen toslidingly receive a guidewire for over-the-wire delivery. In analternative embodiment, first arm 621 and/or second arm 622 includelight source means, such as light provided through a window opticallyconnected to a fiber optic cable, light provided by one or more LEDsand/or light provided via a chemoluminescent solution.

Referring now to FIG. 10C, another preferred embodiment of a scaffoldingdevice of the present invention is illustrated. Located on the distalend of elongate shaft 601 is a deployable scaffolding assembly 610 b.Scaffolding assembly 610 b (similar to is configured to scaffold open abody cavity such as the uterus, while also providing an operating spaceto perform one or more procedures such as tissue removal. Scaffoldingassembly 610 b make be arranged in one or more shapes, such as toconform to specific body areas such as the contour of uteral wall.Scaffolding assembly 610 b comprises three resiliently biased arms,first arm 621, second arm 622 and third arm 623. In an alternativeembodiment, four or more arms may be included. These arms, preferablyconstructed of Nitinol, are configured to be radially compressed whendrawn into the distal end of a tube, such as the lumen of the introducerof the present invention (see FIG. 10D). Shaft 601 preferably includesone or more lumens, such as a lumen to slidingly receive a guidewire forover-the-wire delivery. In an alternative embodiment, first arm 621,second arm 622 and/or third arm 623 include light source means, such aslight provided through a window optically connected to a fiber opticcable, light provided by one or more LEDs and/or light provided via achemoluminescent solution.

Referring now to FIG. 10D, a preferred embodiment of a system 10consistent with the present invention is illustrated. System 10 includesintroducer 100, scaffolding device 600 a and treatment device 500.Introducer 100 d includes sheath 110, device insertion port 120 andfluid transfer port 123, all of similar construction to similarcomponents of introducers 100 a, 100 b and 100 c, 100 d, 100 e, 100 fand 100 g hereabove. Introducer 100 has been placed and advanced suchthat its distal portion resides within cervix C and its distal endprovides access within uterus U of a patient.

Scaffolding device 600 a, of similar construction to the scaffoldingdevice of FIG. 10B, has been advanced through a lumen of introducer 100such that the distal end of shaft 601 and scaffold assembly 610 a (fullyexpanded) reside within the uterus U such that a scaffolding force isapplied to the uteral wall along a plane relatively perpendicular to thecross section shown in FIG. 10D. First arm 621 and second arm 622 havebeen positioned at locations away from uteral fibroid F as shown in FIG.10D. Treatment device 500 has been coaxially advanced through a lumen ofshaft 601 of scaffolding device 600 a such that the distal portion ofshaft 501 resides with uterus U. At the distal end of shaft 501 istreatment element 510, such as a morcellator or other tissue treatmentelement. Via deflection means, not shown but preferably a pull-wireinternal to shaft 501, treatment element 510 has been brought in closeproximity to fibroid F, also as shown in FIG. 10D.

In an alternative embodiment, treatment catheter 500, scaffolding device600 a and/or introducer 100 include a visualization apparatus such as acamera to visualize inside uterus U, such as when clear fluid isintroduced into uterus U via port 123. Light may be provided, as hasbeen described in detail hereabove, from a functional element integralto the distal portions of treatment catheter 500 (e.g. proximate acamera which is proximate treatment element 510), scaffolding device 600a (e.g. in one or more of arms 621 and 622) and/or introducer 100 (e.g.a forward beam light source) such as to improve the image provided tothe clinician via the integral camera. In one embodiment, the camera isan infrared camera and heated and/or cooled solutions are utilized toincrease the contrast in the infrared image (tissue temperaturedifferences) and reduce or eliminate the need for an external lightsource.

In the performance of one or more gynecologic and urologic procedures,such as a tissue removal or other treatment procedure, scaffoldingdevice 600 a and treatment device 500 are repositioned, such as toscaffold a different part of the uterus or to access a different portionof tissue, respectively. In a preferred embodiment, a second scaffoldingdevice is inserted through introducer 100, simultaneous with or at adifferent time than scaffolding device 600 a resides within introducer100. In another preferred embodiment, a second treatment device isinserted through introducer 100, simultaneous with or at a differenttime than treatment device 500 resides within introducer 100.

Referring now to FIG. 11, a preferred embodiment of a visualizationapparatus of the present invention is illustrated. Camera device 700consists of shaft 701, preferably an elongate shaft with a deflectabletip, which includes camera assembly 702 in its distal end portion.Camera assembly 702, which preferably includes a sealed lens or windowon its outer portion, includes one or more configurations as has beendescribed hereabove, including one or more components or assembliesselected from the group consisting of: lenses including filteringlenses, wide angle lenses, gradient lenses and focusing lenses; mirrors;image sensors such as a CCD module; MEMS gyroscopes (such as to detectand accommodate for motion); MEMS mirrors; light sources such as LEDs;strain gauges (such as to detect and accommodate for motion);accelerometers (such as to detect and accommodate for motion); fiberoptic cable for image transfer; other optical or image processingcomponents and combinations thereof. Camera assembly 702 may be arrangedas an endoscope, and/or may involve different technologies such as MEMSactuators, CCD modules and motion detectors which are configured toprovide a stabile image to a clinician despite camera movement. In analternative embodiment, an output port, not shown, is located proximateto camera assembly 702 such that saline or other biocompatible liquidmedia in fluid communication with the output port can be flushed bycamera assembly 702 such as to clear debris and improve image quality.Camera device 700 provides an image to a display, not shown butpreferably a laptop screen as has been described in reference to FIG. 5,such as through an electrical and/or optical connection on a handle ofcamera device 700.

The visualization apparatus of FIG. 11 further includes a first lightsource 710 which is independent (e.g. independently maneuverable) fromcamera device 700. First light source 710 includes shaft 711, preferablyan elongate shaft with a deflectable tip, which includes light emittingelement 712 at its distal end. Light emitting element 712 is a tubularstructure which can be shaped, via pull wire technology described aboveand/or via plastic deformation (e.g. plastically deformable wireincluded within light emitting element 712) such as to wrap around theuterus as shown in FIG. 11. Light emitting element 712 is preferably aself-contained light source, such as an array of light emitting diodesthat are surrounded by a window such as a diffracting orlight-scattering lens. In an alternative embodiment, light emittingelement 712 does not include a light source, but rather consists of aviewing window in optical communication with one or more fiber opticcables which in turn connect to a light source, the light source beingintegral to first light source 710 (such as in a handle of the device)or external and optically connected to first light source 710. Lightemitting element 712, or a separate light source that supplies lightemitting element 712, is connected to a source of electrical power suchas a battery (e.g. a battery in a handle of the device). In analternative embodiment, light emitting element 712 emits light from achemoluminescent solution (e.g. a chemoluminescent solution that ismixed on demand by the clinician, such as by one or more controls on thehandle of the device). This light generating solution, as in found incommercially available “lightsticks”, may be contained (sealedcompartment) within light emitting element 720, or be opticallyconnected to element 720 via a fiber optic cable. In an alternativeembodiment, the chemoluminescent solution is introduced into lightemitting element 720 via an infusion lumen. In another alternativeembodiment, both a chemoluminescent solution and another source of light(e.g. LED light) are provided by light emitting element 720.

The visualization apparatus of FIG. 11 further includes a second lightsource 720 which is also independent (e.g. independently maneuverable)from camera device 700. Second light source 720 includes shaft 721,preferably an elongate shaft with a deflectable tip, which includeslight emitting element 722 at its distal end. Light emitting element 722is a balloon structure which can be inflated and deflated by theclinician, shown in the inflated or partially inflated state in FIG. 11.Light emitting element 722 is preferably a self-contained light source,such as a vessel into which chemoluminescent solution is delivered, ashas been described hereabove. Alternatively, one or more light emittingdiodes that are surrounded by a covering (the balloon) which isconfigured as a diffracting or light-scattering lens. In an alternativeembodiment, light emitting element 722 does not include a light source,but rather consists of a viewing window (the balloon) in opticalcommunication with one or more fiber optic cables which in turn connectto a light source, the light source being integral to second lightsource 720 (such as in a handle of the device) or external and opticallyconnected to second light source 720. Light emitting element 722, or aseparate light source that supplies light emitting element 722, may beconnected to a source of electrical power such as a battery. In thepreferred embodiment, light emitting element 722 emits light from achemoluminescent solution (e.g. a chemoluminescent solution that ismixed on demand by the clinician and injected into the balloon of lightemitting element 722, such as by one or more controls on the handle ofthe device) and does not require the source of electrical power. In analternative embodiment, both a chemoluminescent solution and anothersource of light (e.g. LED light) are provided by light emitting element722.

Camera device 700, first light source 710 and second light source 720have had their distal ends placed through the cervix C and into theuterus C of a patient. In an alternative embodiment, the introducer ofthe present invention is placed into the cervix C, and camera device700, first light source 710 and/or second light source 720 are passedinto the uterus U via the introducer. In another alternative embodiment,one or more of the previous devices resides outside of the introducer,such as to stabilize that device in the uterus. Each device preferablyincludes a handle on their proximal end, not shown but preferablyincluding one or more controls including but not limited to: knobs orlevers to manipulate one or more pull wires configured to manipulate thedistal portions of the associated device; a control to zoom in or zoomout an image; a control to focus an image; a control to stabilize animage; a control to energize a light source; a control to change thelight intensity of a light source (e.g. via change to energy supplied);a control to deliver a drug; a control to change the speed of a tissueremoval assembly; a “Kill-switch” control to stop motion of a componentimmediately; other controls and combinations thereof.

In addition to the above controls, each handle may include one or moreports, such as ports selected from the group consisting of: a valvedport such as a cracking pressure valved port, a two-way valved port anda duckbill valved port; a Tuohy-Borst valve; a fluid stasis valve; adevice insertion port such as a port configured to accept a treatmentdevice of the present invention; an infusion lumen access port such asan infusion lumen in fluid communication with a drug reservoir, exitport or other component of a drug delivery element; a balloon inflationlumen access port; other ports and combinations thereof. In a preferredembodiment, camera device 700, first light source 710 and/or secondlight source 720 include one or more integral functional elements suchas a drug delivery element or other functional element as have beendescribed hereabove. In a preferred embodiment, the functional elementis an integral inflatable balloon, not shown but preferably in a distalportion of the device and configured to: occupy space in the uterus,deflect the distal end of the associated device by applying a force tothe uteral wall; apply tamponade force to the uteral wall, or distendthe uterus.

The distal portions of camera device 700, first light source 710 andsecond light source 720 may be manipulated in the uterus U such as toperform a secondary function including but not limited to: applying atamponade force to a portion of the uteral wall (e.g. a perforation orbleed); to distend the uterus; and combinations thereof. The distalportions of camera device 700, first light source 710 and second lightsource 720 have an “effective” outer diameter (e.g. the ID of anappropriate sheath 110 of the present invention) less than 9 mm,preferably between 5 and 8 mm, and more preferably less than 6 mm.

Referring now to FIG. 12, a preferred embodiment of a volume occupyingdevice of the present invention is illustrated. Volume occupying device800 consists of shaft 801, preferably an elongate shaft with adeflectable tip, which includes volume occupying balloon 802 in itsdistal end portion. Inflation of balloon 802 is accomplished byadministering fluid such as saline from an inflation port, not shown butpreferably on a handle on the proximal end of device 800. Balloon 802may be a compliant balloon such expands to variable volumes based on thefluid pressure, or a non-compliant balloon configured to expand to afixed volume, relatively independent of fluid pressure. Balloon 802 ispreferable includes nylon and/or PET materials. Balloon 802 isconfigured to assume a shape when inflated that approximated the shapeof the uterus or a portion of the space of the uterus, as shown in FIG.12. Inflation of balloon 802 is performed to accomplish one or more ofthe following functions: distend uterus U; effectively “cover” a portionof tissue surface area of uterus U such that fluids internal to uterus Uwill not be absorbed by or otherwise pass through that covered portionof tissue; apply a tamponade force to a portion of the uteral wall (e.g.a bleed or puncture site); occupy space of the uterus to reduce injectedfluid volume; and other functions. In a preferred embodiment, device 800performs at least two functions listed immediately hereabove. In anotherpreferred embodiment, device 800 performs the function of distendingtissue (e.g. the uteral wall) as well as limiting the transfer of fluidsinto or through that tissue.

Also shown in FIG. 12 is treatment catheter 500, including an elongateshaft 501 and a treatment element 510 near the distal end of shaft 501.Treatment catheter 500, for example a tissue removal or denaturingdevice or a drug delivery device, is being advanced such as to alocation to the right and above balloon 802 of volume occupying device800. Advantages of placement of volume occupying device 800 include thefunctions in the paragraph above, as well as creating a small “workarea” for the clinician to navigate with treatment catheter 500.

In an alternative embodiment, the introducer of the present invention isplaced into the cervix C, and volume occupying device 800 and/ortreatment catheter 400 are passed into the uterus U via the introducer.In another alternative embodiment, one or more of the previous devicesresides outside of the introducer, such as to stabilize that device inthe uterus.

Referring additionally to FIG. 12A, a shaping wire 560 including shape561 near its distal end is shown. Shaping wire 560, preferably aheat-set shaped Nitinol wire, is configured to be inserted into a lumenof a device, such as a lumen of volume occupying device 800 or treatmentcatheter 500, lumens not shown. Clinician insertion of shaping wire 560causes the distal portion of the device in which wire 560 is inserted,to change shape in a pre-determined manner. This shape-changing functionallows the clinician to position one or more components of the devices(e.g. balloon 802 or treatment element 510), at a specific locationwithin uterus U. In a preferred embodiment, shaping wire 560 isconfigured to be inserted into a lumen of one or more of theintroducers, treatment catheters, distension devices, volume occupyingdevices, visualization apparatus, navigating apparatus or other devicesof the present invention such as to modify the shape of a distal portionof the device.

Referring now to FIG. 13, a preferred method and associated system ofthe present invention is disclosed. Numerous procedural steps listedbelow in reference to FIG. 13 have been described in detail throughoutthis specification. For brevity, the details of each step will not berepeated below but should be considered within the scope of the methodand system of FIG. 13 as has been described hereabove.

Step 10 involves placing one or more devices to dilate the cervix of apatient. Prior to, during and/or shortly after the dilation of Step 10,Step 11 may be performed which is the measurement of one or more patientparameters, such as patient physiologic parameters. Patient physiologicparameters include but are not limited to: force exerted by or on tissuesuch as force exerted by or on the cervix as measured by a transducerintegral to a cervical dilator; EKG; EEG; blood and blood gas parameterssuch as cell counts and 02 saturation levels; glucose parameters; pH;blood pressure; respiration; and combinations thereof.

Subsequent to Step 10, Step 20 involves the dilation of the patient'scervix. The dilation is performed per a set of dilation parameters, suchparameters including but not limited to: pressure of dilation such asballoon pressure; amount of dilation per unit time; pressure increaseper unit time; rate of change of dilation per unit time; rate of changeof pressure increase per unit time; duty cycle of discontinuous dilation(e.g. on and off times if dilation performed in discrete time segments);frequency of discontinuous dilation; other dilation parameters andcombinations thereof.

Simultaneous with the performance of the dilation of Step 20, Step 30 isperformed in which one or more patient parameters, as have been listedabove in reference to Step 11, are taken. Step 40 is performed, in whichthe one or more parameters are analyzed and the results of the analysisis compared to a threshold. If a threshold is exceeded, that informationis fed to the parameter modifying algorithm of Step 50, which in turnmodifies one or more of the dilation of parameters of Step 20 (such asto decrease dilation pressure or stop dilation entirely). If thethreshold is not exceeded, that information is fed back to the dilationcontrol of Step 20 and no change is made.

For example, if one of the patient parameters collected in Step 30 isblood pressure, which may be an acceptable surrogate for pain level,when a previously determined blood pressure threshold is reached,dilation is reduced or stopped. The parameter analysis may be moresophisticated that comparing the physiologic measurement to a directthreshold, other analysis made additionally or alternatively beperformed such as to look at rate of change of the parameter, or toanalyze two or more parameters in combination: such as two or more ofEKG, blood pressure and respiration.

In a preferred embodiment, a system is provided to automatically performthe parameter analysis of Step 40 and automatically modify the dilationparameters of Steps 50 and 20. In an alternative embodiment, theclinician may perform one or more steps, or perform a portion of one ormore steps manually. In another preferred embodiment, one or morethresholds involved with the analysis are programmable by the clinician.In another preferred embodiment, the mathematical formulas of theanalysis are programmable by the clinician.

The dilation performed in Step 20 may be accomplished with continuousapplication of pressure or discontinuously in discrete time segments.These discrete dilation time segments may be fractions of seconds,multiple seconds or even minutes. In a preferred embodiment, theanalysis of the physiologic measurement is performed between dilationtime segments, such that the subsequent dilation time segment ispotentially modified (Step 50) due to the analysis performed in theprevious “off” or no-dilation period.

The “smart” dilation system and method of FIG. 13 is preferablyaccomplished using an introducer of the present invention, such asintroducer 100 c of FIG. 1B which includes strain gauge 113 (output ofstrain gauge 113 is the measured physiologic parameter); or introducer100 eof FIG. 4 which includes pressure sensor 154 integral to dilatingballoon 116 (output of sensor 154 is the measured physiologicparameter). Other devices of the present invention may include afunctional element such as a pressure or other force sensor whichprovides an output signal that includes the physiologic data analyzed inStep 40.

In an alternative embodiment, the “smart” dilation system and method ofFIG. 13 may deliver a drug based on the physiologic data analysis ofStep 40, in addition to or alternative to modifying the dilationparameters in Step 50. In a preferred embodiment, a threshold for oneanalysis (based on one or more physiologic data) causes a drug to bedelivered, and the threshold for a second analysis (based on similar ordissimilar physiologic data analysis used in the first analysis) causesa dilation parameter to be changed (including cessation of dilation).

It should be understood that numerous other configurations of thesystems, devices and methods described herein could be employed withoutdeparting from the spirit or scope of this application. While theprocedures described above have been described in terms of gynecologicalprocedures, other applicable procedures can be incorporated withoutdeparting from the spirit and scope of the invention, particularlyprocedures applicable to both male and female patients.

The scaffolds and volume occupying element of the present inventioncomprise shapes and sizes that preferably allow both visualization (suchas via an internal camera) and treatment (the performance of theintended clinical procedures, such as a tissue treatment procedure).Preferred shapes of these devices include but are not limited to:spherical; conical; trapezoidal; hemispherical; scallop-shaped; andcombinations of the above such as a scaffolding device with a sphericalportion and a conical portion. The size of the volume occupying elementsof the present invention should be more than 5% of the volume of thecavity into which it is inserted (e.g. the uterus) and up to 100% ofthat space (e.g. to allow maximum viewing and working area withoutdamaging tissue such as uteral wall or neighboring tissue).

The devices of the present invention may be provide in kits, such askits that offer various size and shape scaffolding and volume occupyingdevices.

Each device (e.g. treatment device) could be used in various areas—notjust Uterus

Each device (e.g. treatment device) could be used in various proceduretypes such as: percutaneous, laparoscopic, MIS, open surgery

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims. In addition,where this application has listed the steps of a method or procedure ina specific order, it may be possible, or even expedient in certaincircumstances, to change the order in which some steps are performed,and it is intended that the particular steps of the method or procedureclaim set forth herebelow not be construed as being order-specificunless such order specificity is expressly stated in the claim.

1. A method of preventing intravasation during an intrauterineprocedure, comprising the steps of: transcervically accessing the uteruswith an elongate tubular sheath; introducing a mechanical distensiondevice through the sheath and into the uterus; using the mechanicaldistension device to distend the uterus and expose a site; andperforming a procedure at the site.
 2. A method of preventingintravasation during an intrauterine procedure as in Claim 1, whereinthe transcervically accessing step comprises advancing the sheath over aguidewire.
 3. A method of preventing intravasation during anintrauterine procedure as in claim 1, wherein the transcervicallyaccessing step is accomplished under local anesthesia.
 4. A method ofpreventing intravasation during an intrauterine procedure as in claim 1,wherein the using the mechanical distension device step achieves anequivalent distension to that achieved by introduction of a liquiddistension media at a pressure of at least 40 mm Hg.
 5. A method ofpreventing intravasation during an intrauterine procedure as in claim 1,wherein the using the mechanical distension device step achieves anequivalent distension to that achieved by introduction of a liquiddistension media at a pressure of about 70 mm Hg.
 6. A method ofpreventing intravasation during an intrauterine procedure as in claim 1,further comprising the step of dilating the cervix prior to thetranscervically accessing step.
 7. A method of preventing intravasationduring an intrauterine procedure as in claim 1, wherein the performing aprocedure step comprises treating a uterine fibroid.
 8. A method ofperforming a procedure in the uterus, comprising the steps of:transcervically accessing the uterus with an elongate flexible tubularsheath, having a proximal end, a distal end and at least one lumenextending therethrough, the sheath having an outside diameter of no morethan about 9 mm; distending the uterus to expose a site; introducing avisualization device through the sheath, to visualize the site, andperforming a procedure at the site.
 9. A method of performing aprocedure in the uterus as in claim 8, wherein the method is adiagnostic method.
 10. A method of performing a procedure in the uterusas in claim 8, wherein the method is a therapeutic method.